KONING BREAST CT (MODEL CBCT1000)
FDA premarket approval P130025 · decided 2015-01-14
Approval details
- PMA number
- P130025
- Trade name
- KONING BREAST CT (MODEL CBCT1000)
- Generic name
- Cross-sectional mammographic xray system
- Applicant
- Koning Corporation
- Date received
- 2013-11-25
- Decision date
- 2015-01-14
- Days to decision
- 415 days
- Decision code
- APPR
- Product code
- OLQ
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- W Henrietta, NY
- Statement
- APPROVAL FOR THE KONING BREAST CT (MODEL CBCT 1000). THIS DEVICE IS INDICATED AS FOLLOWS: KONING BREAST CT (CBCT1000) IS A CONE BEAM COMPUTED TOMOGRAPHY SYSTEM INTENDED TO PROVIDE THREE DIMENSIONAL IMAGES FOR DIAGNOSTIC IMAGING OF THE BREAST. KONING BREAST CT SHOULD BE READ ALONG WITH STANDARD 2-VIEW MAMMOGRAPHY (CC AND MLO VIEWS).
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